NCT02305680

Brief Summary

This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

December 17, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

2.3 years

First QC Date

November 18, 2014

Last Update Submit

September 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians

    From 2 years after the acute coronary syndrome index event, assessed up to 5 years

Secondary Outcomes (3)

  • Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events

    From 2 years after the acute coronary syndrome index event, assessed up to 5 years

  • Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost.

    From 2 years after the acute coronary syndrome index event, assessed up to 5 years

  • Quality of life by assessing EQ-5D questionnaire.

    2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a history of acute coronary syndromes in China

You may qualify if:

  • Written informed consent has been provided.
  • Contact Order Form has been provided
  • Aged 18 years or older.
  • Enrolled in EPICOR Asia study and completed the 2 year follow-up.

You may not qualify if:

  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse).
  • Already included in the EPICOR Asia-China Extension observational study.
  • Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
  • Current participation in an interventional clinical trial.
  • Patients receiving ticagrelor beyond 12 months and other off label use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Research Site

Baoding, China

Location

Research Site

Beijing, China

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Research Site

Changzhi, China

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Chongqing, China

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Guangzhou, China

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Guiyang, China

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Haerbin, China

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Hangzhou, China

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Hebei, China

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Jilin, China

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Jinan, China

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Jinzhong, China

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Kunming, China

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Lanzhou, China

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Nanjing, China

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Nanning, China

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Shanghai, China

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Shenyang, China

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Shenzhen, China

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Shihezi, China

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Taiyuan, China

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Tangshan, China

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Tianjin, China

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Ürümqi, China

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Wuhan, China

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Wuxi, China

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Xi'an, China

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Xining, China

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Xuzhou, China

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Yinchuan, China

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Yulin, China

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Zhengzhou, China

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Research Site

Zhenjiang, China

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Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yong Huo, Doctor

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

December 3, 2014

Study Start

December 17, 2014

Primary Completion

April 5, 2017

Study Completion

April 5, 2017

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations